A Study of LY900014 in Participants With Type 1 Diabetes... | NCT03465878

ID	Type	Description	Link
I8B-MC-ITSA	Other Identifier	Eli Lilly and Company
2017-003220-78	EudraCT Number

A Study of LY900014 in Participants With Type 1 Diabetes... | NCT03465878 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY900014-Part A	Experimental	Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.	Drug: LY900014
Humalog (Insulin Lispro)-Part A	Active Comparator	Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog.	Drug: Insulin Lispro
LY900014-Part B	Experimental	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the continuous subcutaneous insulin infusion (CSII) pump.	Drug: LY900014
Humalog (Insulin Lispro)-Part B	Active Comparator	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.	Drug: Insulin Lispro

Name	Type	Description	Arm Group Labels	Other Names
LY900014	Drug	Administered via SC injection	LY900014-Part A LY900014-Part B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part	Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.	Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose

Secondary Outcomes

Measure	Description	Time Frame
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part	Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part.	-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240 and 300 minutes postdose

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
LMC Endocrinology Centres Ltd.		Toronto	Ontario	M4G 3E8	Canada
Kinderkrankenhaus auf der Bult

Label	URL
A Study of LY900014 in Participants With Type 1 Diabetes Mellitus	View source

Arm/Group Information

ID	Title	Description
FG000	Sequence 1-Part A	Participants received either single 0.2 units per kilogram (U/kg) of body weight subcutaneous (SC) bolus injection of 100 units per milliliter (U/mL) LY900014 or Humalog. Period 1: LY900014 Period 2: Humalog
FG001	Sequence 2-Part A	Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: Humalog Period 2: LY900014
FG002	Sequence 1-Part B	Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog delivered using the continuous subcutaneous insulin infusion (CSII) pump. Period 1: LY900014 Period 2: Humalog
FG003	Sequence 2-Part B	Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog with delivered using the CSII pump. Period 1: Humalog Period 2: LY900014

Periods

Title

Milestones

Reasons Not Completed

Period 1-Part A First Intervention Day 1

Type	Comment	Milestone Data
STARTED		FG00021 subjects FG00121 subjects FG0020 subjects FG0030 subjects
Received at Least 1 Dose of Study Drug		FG00021 subjects FG00121 subjects FG0020 subjects FG0030 subjects
Children (2-11 Years)		FG0007 subjects FG0016 subjects FG0020 subjects FG0030 subjects
Adolescents (12-17 Years)		FG0007 subjects FG0017 subjects FG0020 subjects FG0030 subjects
Adults (18-64 Years)		FG0007 subjects FG0018 subjects FG0020 subjects FG0030 subjects
COMPLETED		FG00021 subjects FG00120 subjects FG0020 subjects FG0030 subjects
NOT COMPLETED		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0000 subjects FG0011 subjects FG0020 subjects FG003

Period2-Part A Second Intervention Day 1

Type	Comment	Milestone Data
STARTED		FG00021 subjects FG00120 subjects FG0020 subjects FG003

Period 1-Part B First Intervention Day 1

Type	Comment	Milestone Data
STARTED		FG0000 subjectsThis period is for Part B group. FG0010 subjectsThis period is for Part B group. FG00220 subjects25 pts from Part A were re-randomized to Part B, 14 new pts were randomized in Part B. FG003

Period2-Part B Second Intervention Day 1

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG00220 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Part A	Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog.
BG001	Part B	Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of either 100 U/mL LY900014 or Humalog delivered using the CSII pump.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.

All randomized participants who received at least one dose of study drug and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

Picomoles*hour/Liter (pmol*h/L)

Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose

ID	Title	Description
OG000	Children-LY900014-Part A	Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
OG001	Children-Humalog-Part A

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Children-LY900014-Part A	Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hypothyroidism	Endocrine disorders	MedDRA 21.1	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chief Medical Officer	Eli Lilly and Company	800-545-5979		ClinicalTrials.gov@lilly.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 20, 2018	Apr 21, 2020	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Aug 6, 2018	Apr 21, 2020	SAP_001.pdf

Condition Browse Module

ID	Term
D003922	Diabetes Mellitus, Type 1

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Intervention Browse Module

ID	Term
D061268	Insulin Lispro

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Children (2-11 Years)	BG00013 BG0013 BG00216
Adolescents (12-17 years)	BG00014 BG0012 BG00216
Adults (18-64 years)	BG00015 BG0019 BG00224

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0010 BG0022
Not Hispanic or Latino	BG00040 BG00114 BG00254
Unknown or Not Reported	BG0000 BG0010 BG0020

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG0001 BG0012 BG0023
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0001 BG0010 BG0021
White	BG00037 BG00111 BG00248
More than one race	BG0003 BG0011 BG0024
Unknown or Not Reported	BG0000 BG0010 BG0020

Title

Denominators

Categories

Title	Measurements
	OG000755± 15 OG001754± 17 OG002962± 17 OG003908± 21 OG004987± 20 OG005975± 21 OG006743± 17 OG007714± 17 OG008842± 20 OG009866± 16 OG0101100± 35 OG0111070± 35

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	0.9813	Ratio of geometric least squares means	0.999	2-Sided	95	0.918	1.09	Superiority
OG002 OG003	Mixed Models Analysis	0.1638	Ratio of geometric least squares means	1.06	2-Sided	95	0.976	1.15	Superiority
OG004 OG005	Mixed Models Analysis	0.7623	Ratio of geometric least squares means	1.01	2-Sided	95	0.933	1.10	Superiority
OG006 OG007	Mixed Models Analysis	0.2952	Ratio of geometric least squares means	1.04	2-Sided	95	0.962	1.13	Superiority
OG008 OG009	Mixed Models Analysis	0.4052	Ratio of geometric least squares means	0.970	2-Sided	95	0.901	1.04	Superiority
OG010 OG011	Mixed Models Analysis	0.5314	Ratio of geometric least squares means	1.02	2-Sided	95	0.948	1.11	Superiority

Secondary

Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part

Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part.

All randomized participants who received at least one dose of study drug and had evaluable Glucodynamics data.

Posted

Mean

Standard Deviation

milligrams*hour per deciliter (mg*h/dL)

-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240 and 300 minutes postdose

ID	Title	Description
OG000	Children-LY900014-Part A	Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
OG001	Children-Humalog-Part A	Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
OG002	Adolescents-LY900014-Part A	Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.
OG003	Adolescents-Humalog-Part A	Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
OG004	Adults-LY900014-Part A	Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014.
OG005	Adults-Humalog-Part A	Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
OG006	Children-LY900014-Part B	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
OG007	Children-Humalog-Part B	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
OG008	Adolescents-LY900014-Part B	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
OG009	Adolescents-Humalog-Part B	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
OG010	Adults-LY900014-Part B	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
OG011	Adults-Humalog-Part B	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Units	Counts
Participants	OG00012 OG00112 OG00213 OG003

Title

Denominators

Categories

Title	Measurements
	OG000384± 335 OG001492± 270 OG002577± 247 OG003